MSD Manager Regulatory Affairs 

Malaysia, Selangor 

28014308

Job Description

Manager, Regulatory Affairs

• Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
• Join the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years .

Key Responsibilities:

• Develop and implement regulatory strategy to accelerate products and indications pipeline
• Drive regulatory policy shaping initiatives with local regulatory agency, trade association and other external stakeholders.
• Ensure regulatory support through product life cycle including labelling, CMC and dossier modifications
• Coordinate the preparation of post-approval regulatory documents in accordance with agreed timeframes
• Lead/participate in negotiations during regulatory approval processes for applications with the regulatory agencies
• Participate in inter-company organizations focusing on specific industry-related issues
• Keep abreast on all regulatory requirements (local, ASEAN, ICH, WHO), market, and industry developments
• Build long term effective relationships and keeps open communication with Regional / Global colleagues
• Monitor regulatory agencies and industry changes, trends and requirements to contribute effectively to product development and regulatory strategies
• Cooperate with other departments to collect information needed for recall reporting, including initial and follow-up reports, and others
• Contribute with regulatory support during health authority site inspections
• Attend inter-departmental meetings discussing product issues and priorities to develop clear and concise plans with milestones to reach the desired outcomes
• Participate in development of regulatory strategies for product changes, to ensure compliance with the current regulatory requirements
• Participate in working and industry groups to provide input to shape the regulatory landscape and maintain prospective awareness of evolving regulatory expectations
• Serves as a local in-house CMC expert and able to provide a specialized perspective for product life-cycle management.

Education Minimum Requirement:

• Graduates with Pharmacy degree or graduates with Science related degree eg BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
• First class honours or high second upper degree
  

Required Experience and Skills:

• Registered pharmacist are encouraged to apply
• A minimum of 10 years of relevant pharmaceutical regulatory experience, preferably with MNC background, including experience in regulatory affairs policy shaping and CMC
• Ability to communicate well verbally and in writing to internal and external stakeholders is essential
• Detail oriented, meticulous and organized
• Has basic IT knowledge
• Able to work within targeted timelines
• Advanced project management skills
• Self-motivated and strong commitment to achieve desired results and right first time
• Team player

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.